Proliferative disorders, such as cancer, are caused by uncontrolled and unregulated cellular proliferation. Such cellular proliferation can lead to the formation of tumours in the relevant subjects.
Typically tumours, such as brain tumours, are initially clinically identified within a subject by way of various well known pre-screening imaging techniques, such as computed tomography (CT), magnetic resonance imaging (MRI), X-Rays, and positron emission tomography (PET). Such imaging techniques are, however, expensive to deploy given the high cost of both the equipment itself and the human resources required to operate it. Some such imaging techniques require complex operation by highly qualified professionals, and some require time consuming analysis before conclusions can be drawn. Moreover, such techniques seldom, if ever, distinguish between benign and malignant tumours. As such, a final biopsy is always required to confirm the malignancy or benignity of a given tumour.
Biopsies require invasive surgery to extract a relevant tissue sample. In the case of brain tumours, biopsies generally require drilling into the subject's skull, which is a highly dangerous and skilled surgical operation. The subject having undergone such a biopsy is then typically hospitalised for two to three days, which presents an undesirable care burden. Once the biopsy has been successfully performed, it can take a significant period of time before the malignancy or benignity of the relevant tumour is actually determined.
It is therefore highly desirable to provide a pre-screening tool that is cost-effective, requires minimal human resource and skill to operate, and does not involve time consuming analysis. It is moreover desirable to provide a pre-screening technique that facilitates relatively fast determination of malignancy or benignity of tumours with a reasonably high degree of accuracy, and without the drawbacks inherent with biopsies.
In recent times, various biomarkers within the blood have been identified as useful indicators of particular diseases. For instance, cytokines, chemokines, and growth factors are cell signaling proteins that mediate a range of physiological responses, and are associated with various diseases. Such molecules are generally detected by either bioassay or immunoassay, both of which can be time consuming given that often only one analyte may be analysed at a time. However, in more recent times, magnetic bead-based multiplex assays designed to measure multiple cytokines, chemokines, and growth factors in diverse matrices like serum, plasma, and tissue culture supernatants, have become more readily available with kits such as Bio-Plex Pro™ (see Bio-Plex Pro™ Assay Handbook—http://www.bio-rad.com/webroot/web/pdf/lsr/literature/10014905.pdf). However, the complexities associated with the correlation of particular biomarkers with particular diseases has retarded developments in the medical diagnostics field, and such correlations are inherently unpredictable at present. Moreover, such assaying still requires a reasonable level of skill, and such assays also destroy the sample in question such that repeat assays on the same sample are not possible. Validation of results is thus more difficult.
In other developments in the field of medical diagnostics, a recent study has shown the potential of infra-red (IR) spectroscopy in the analysis of serum to discriminate myocardial infarction from other chest pain [Petrich W, Lewandrowski K B, Muhlestein J B, Hammond M E D, Januzzi J L, Lewandrowski E L, Pearson R R, Olenko B, Fruh J, Haass M, Hirschi M M, Kohler W, Mischler R, Mocks J, Ordonez-Llanos J, Quarder O, Somorjai R, Staib A, Sylven C, Werner G, Zerback R Analyst, 134(6), 2009; 1092-1098]. Spectroscopic diagnostic methods such as this could be highly desirable for both clinicians and patients if they could be made clinically viable, since they potentially offer a non-destructive, rapid, cost-effective, simple to operate point-of-care diagnosis of a condition. However, at present, it would appear that the applicability of such spectroscopic diagnostic techniques is somewhat limited in scope, given their questionable reliability in the face of sample variance.
It is therefore an object of the present invention to solve at least one of the problems inherent with the prior art. Another object is to provide a simple, reliable, and cost-effective point-of-care diagnostic method that requires minimal human resource and skill to operate, is non-time consuming, and which facilitates rapid determination of malignancy/benignity of tumours with a reasonably high degree of accuracy.